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RECRUITING

NCT06332534

PHASE3

Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease

Sponsor: AbbVie

View on ClinicalTrials.gov

Summary

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective oral Upadacitinib is in treating moderately to severely active Crohn's Disease in pediatric participants aged 2 to 18 years old who have had inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy. Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active CD and is being developed for moderate- to severely active CD in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: a 12-week open-label induction phase which means that the study doctor and participants know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 52-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given (UPA Dose B or Dose C). Period 2 is a 156-week open-label extension of Period 1. Approximately 110 pediatric participants with moderate to severely active CD will be enrolled at approximately 92 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will have a safety follow up for 30 days after discontinuation from any time point within the study. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Official title: A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib With Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects With Moderately to Severely Active Crohn's Disease and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2024-08-08

Completion Date

2034-12

Last Updated

2026-04-06

Healthy Volunteers

Conditions

Crohn's Disease

Interventions

DRUG

Upadacitinib

Oral Solution/ Extended-Release Tablets

Inclusion Criteria: * Weight at Screening and Baseline must be \>= 10 kg * Moderate to severe Crohn's Disease (CD) defined as Pediatric Crohn's Disease Activity Index (PCDAI) \> 30 and endoscopic evidence of mucosal inflammation as documented by a centrally read SES-CD of \>= 6 (or SES-CD of \>=4 for isolated ileal disease) excluding the presence of narrowing component. * Documented diagnosis of CD prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of CD, in the assessment of the investigator, must be available * Demonstrated an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators (IMMs), and/or biologic therapy or in whom use of those therapies is medically contraindicated. For participants in the US and South Korea, participants must have demonstrated an inadequate response, loss of response, or intolerance to one or more anti-TNFs (tumor necrosis factor). Exclusion Criteria: * History of: * A diagnosis of CD prior to 2 years of age. * Currently known complications of CD such as: * Active abscess (abdominal or perianal); * Symptomatic bowel strictures; * More than 2 missing segments of the following 5 intestinal segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum; * Ostomy or ileoanal pouch; * Surgical bowel resection within the past 3 months prior to Baseline, or a history of more than 3 bowel resections. * Japan participants only: positive result of beta-D-glucan or two consecutive indeterminate results of beta-D-glucan during the Screening period (screening for Pneumocystis jiroveci infection) * History of any of the following: * Current diagnosis of ulcerative colitis (UC), indeterminate colitis, or monogenic inflammatory bowel disease (IBD); * Fulminant colitis or toxic megacolon; * Gastrointestinal (GI) perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment including history of volvulus and/or intussusception (telescoping of bowels); * Current diagnosis of any primary immune deficiency * Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; subjects with a history of gastric banding/segmentation are not excluded.

Locations (83)

UCSF Benioff Children's Hospital - Oakland /ID# 262217

Oakland, California, United States

Lucile Packard Children's Hospital /ID# 262193

Palo Alto, California, United States

Children's Hospital Colorado - Aurora /ID# 262207

Aurora, Colorado, United States

Connecticut Children's Medical Center - Hartford /ID# 262256

Hartford, Connecticut, United States

OSF St. Francis Medical Center /ID# 262192

Peoria, Illinois, United States

Indiana University Health Riley Hospital for Children /ID# 262215

Indianapolis, Indiana, United States

Boston Children's Hospital /ID# 262191

Boston, Massachusetts, United States

MNGI Digestive Health, P. A. /ID# 262204

Minneapolis, Minnesota, United States

Icahn School of Medicine at Mount Sinai /ID# 262216

New York, New York, United States

Univ NC Chapel Hill /ID# 262198

Chapel Hill, North Carolina, United States

UH Cleveland Medical Center /ID# 262188

Cleveland, Ohio, United States

Children's Hospital of Philadelphia - Main /ID# 262197

Philadelphia, Pennsylvania, United States

Sydney Children's Hospital /ID# 262352

Randwick, New South Wales, Australia

Children's Hospital at Westmead /ID# 262350

Westmead, New South Wales, Australia

Queensland Children's Hospital /ID# 262351

South Brisbane, Queensland, Australia

Monash Health - Monash Medical Centre /ID# 262878

Clayton, Victoria, Australia

Perth Children'S Hospital /ID# 272905

Perth, Western Australia, Australia

Uza /Id# 261745

Edegem, Antwerpen, Belgium

Cliniques Universitaires UCL Saint-Luc /ID# 261741

Brussels, Brussels Capital, Belgium

Universitair Ziekenhuis Leuven /ID# 261740

Leuven, Vlaams-Brabant, Belgium

Hospital Universite Enfants Reine Fabiola /ID# 261744

Brussels, Belgium

CHR de la Citadelle /ID# 261749

Liège, Belgium

UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 261750

Namur, Belgium

Galileo Medical Research Ltda /ID# 262602

Juiz de Fora, Minas Gerais, Brazil

Hospital Pequeno Príncipe /ID# 262600

Curitiba, Paraná, Brazil

Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 262601

Porto Alegre, Rio Grande do Sul, Brazil

Rocco & Nazato Servicos Medicos /ID# 262485

São Paulo, São Paulo, Brazil

Hospital Sirio Libanes /ID# 262670

São Paulo, Brazil

UMHAT Sveti Georgi /ID# 262590

Plovdiv, Bulgaria

Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 262589

Sofia, Bulgaria

IWK Health Center /ID# 262543

Halifax, Nova Scotia, Canada

Beijing Children's Hospital /ID# 262258

Beijing, Beijing Municipality, China

Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 262596

Guangzhou, Guangdong, China

The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 272807

Guangzhou, Guangdong, China

Henan Children's Hospital Zhengzhou Children's Hospital /ID# 262300

Zhengzhou, Henan, China

Hunan Children's Hospital /ID# 262512

Changsha, Hunan, China

Jiangxi Provincial Children's Hospital /ID# 262295

Nanchang, Jiangxi, China

Shengjing Hospital of China Medical University /ID# 262301

Shenyang, Liaoning, China

Children's Hospital of Shanghai /ID# 262356

Shanghai, Shanghai Municipality, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 262502

Shanghai, Shanghai Municipality, China

The Children's Hospital of Zhejiang University School of Medicine /ID# 262337

Hangzhou, Zhejiang, China

CHU de CAEN - Hopital de la Cote de Nacre /ID# 262311

Caen, Calvados, France

Hospices Civils de Lyon - Hôpital Femme Mère Enfant /ID# 263422

Bron, Rhone, France

Hopitaux de Paris (AP-HP) - Hopital Robert Debre - CHU /ID# 262308

Paris, France

Agia Sofia Hospital /ID# 261792

Athens, Attica, Greece

General Hospital of Chest Diseases of Athens SOTIRIA /ID# 261790

Athens, Attica, Greece

University General Hospital of Heraklion PA.G.N.I /ID# 261791

Heraklion, Crete, Greece

Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 262384

San Giovanni Rotondo, Foggia, Italy

Ospedale Pediatrico Bambino Gesù /ID# 262379

Rome, Roma, Italy

Azienda Ospedaliera Universitaria Gaetano Martino /ID# 262380

Messina, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 275276

Milan, Italy

Tsujinaka Hospital - Kashiwanoha /ID# 262454

Kashiwa-shi, Chiba, Japan

Kurume University Hospital /ID# 262455

Kurume-shi, Fukuoka, Japan

Miyagi Children's Hospital /ID# 262459

Sendai, Miyagi, Japan

Osaka Women's and Children's Hospital /ID# 262549

Izumi-Shi, Osaka, Japan

Saga University Hospital /ID# 262753

Saga, Saga-ken, Japan

Saitama Children's Medical Center /ID# 262461

Saitama-shi, Saitama, Japan

Institute of Science Tokyo Hospital /ID# 262510

Bunkyo-ku, Tokyo, Japan

Tokyo Metropolitan Children's Medical Center /ID# 262550

Fuchu-shi, Tokyo, Japan

National Center For Child Health And Development /ID# 262456

Setagaya City, Tokyo, Japan

Toyama Prefectural Central Hospital /ID# 262739

Toyama, Toyama, Japan

Christchurch Hospital. /ID# 262577

Christchurch, Canterbury, New Zealand

Starship Child Health /ID# 262576

Auckland, New Zealand

Gastromed Sp. z o.o /ID# 262367

Torun, Kuyavian-Pomeranian Voivodeship, Poland

Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 262366

Warsaw, Masovian Voivodeship, Poland

Clinical Research Investigator Group, LLC /ID# 262357

Bayamón, Puerto Rico

Puerto Rico Health Institute /ID# 262358

Dorado, Puerto Rico

Clinical Research Puerto Rico /ID# 279595

San Juan, Puerto Rico

Seoul National University Hospital /ID# 262324

Seoul, Seoul Teugbyeolsi, South Korea

Yonsei University Health System Severance Hospital /ID# 262721

Seoul, Seoul Teugbyeolsi, South Korea

Samsung Medical Center /ID# 262323

Seoul, Seoul Teugbyeolsi, South Korea

Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 262226

Ferrol, A Coruna, Spain

Hospital Sant Joan de Deu /ID# 262599

Esplugues de Llobregat, Barcelona, Spain

Hospital Regional Universitario de Malaga /ID# 262228

Málaga, Spain

Hospital Universitario Virgen del Rocio /ID# 262712

Seville, Spain

Hospital Clinico Universitario Lozano Blesa /ID# 262227

Zaragoza, Spain

National Taiwan University Hospital /ID# 261695

Taipei City, Taipei, Taiwan

Linkou Chang Gung Memorial Hospital /ID# 261696

Taoyuan, Taiwan

Addenbrookes Hospital /ID# 262707

Cambridge, Cambridgeshire, United Kingdom

Sheffield Children's Hospital NHS Foundation Trust /ID# 261832

Sheffield, England, United Kingdom

Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 262811

London, Greater London, United Kingdom

Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 262778

Norwich, Norfolk, United Kingdom

Royal Hospital for Children and Young People /ID# 262388

Edinburgh, United Kingdom

Clinical Research Directory

Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (83)